Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery

Completed

• Conditions: Augmented Reality; Pancreatectomy

• Registration Number: NCT06208579
• Lead Sponsor: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

Brief Summary

Pancreatic cancer necessitates surgical resection for complete tumor eradication, serving as the primary curative approach. However, pancreatic surgery is still challenging due to the organ's retroperitoneal anatomy and proximity to vital vascular systems. Thus, precise preparation and dissection of peripancreatic vessels are crucial during pancreatic surgery to reduce perioperative complications and improve oncological outcomes. The integration of preoperative computed tomography-derived reconstructed images, along with augmenting the resulting 3D model during surgical procedures, holds significant potential in this context. Augmented reality-assistance systems (ARAS) have seen use in various surgical fields, including orthopedic, plastic, and neurosurgery. Nevertheless, the application of ARAS in abdominal surgery has faced challenges related to organ shifting and deformities. The retroperitoneal nature of the pancreas, characterized by minimal intraoperative organ shifts and deformations, makes pancreatic surgery a promising candidate for ARAS. Despite this, there is a limited number of studies exploring the impact of ARAS during pancreatic surgery. Notably, existing investigations have primarily utilized augmented reality technology with 2D-display-based modalities. This prospective study aims to fill this gap by examining the usability, feasibility, and effectiveness of wearable ARAS during pancreatic surgery. By leveraging advanced technology seamlessly integrated into the surgical workflow, this research seeks to provide valuable insights into the practical application of ARAS, potentially enhancing the precision and outcomes of pancreatic surgery. The preliminary findings of this study will also be submitted for publication in a peer-reviewed journal.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-17
• Primary Completion: 2024-09-01
• Study Completion: 2024-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient consent
• Aged above 18 years
• Undergoing any type of pancreatectomy

Exclusion Criteria

• Unresectable tumors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of identified peripancreatic vessels with errors	During surgery

Secondary Outcome Measures

Name	Time	Method
User experience	Day 1	User experience will be assessed using an adapted NASA Task Load Index (NASA-TLX, 5 questions, range, 1-10, with lower scores indicating lower cognitive workload)
Intraoperative blood loss	During surgery
Duration of operation	During surgery
Duration of hospital stay	Three months
Rate of tumor-free resection margin	One week	Rate of tumor-free resection margin after pancreatic resection
Rate of morbidity	Three months	Complications rate after pancreatic resection
Rate of mortality	Three months	All cause death events

Trial Locations

Locations (1)

Klinikum Saarbrücken; 🇩🇪 Saarbrücken, Saarland, Germany